Clinical Trial: Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label Registry Study of the Facial Lipoatrophy Correction Experience With SCULPTRA® in Subjects With Human Immunodeficiency Virus (FACES

Brief Summary: 5 year, open-label study to evaluate safety of SCULPTRA on the signs of lipoatrophy of the face in at least 100 evaluable subjects with human immunodeficiency virus.

Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome: To evaluate, by Fitzpatrick skin type and by gender, long-term safety of Poly-L-Lactic acid injection(s) in human immunodeficiency virus subjects with facial lipoatrophy. [ Time Frame: 5 years ]

Original Primary Outcome: To evaluate, by Fitzpatrick skin type and by gender, long-term safety of Poly-L-Lactic acid injection(s) in human immunodeficiency virus subjects with facial lipoatrophy.

Current Secondary Outcome:

  • Evaluate the incidence of hypertrophic scars or keloids in subjects by Fitzpatrick skin types IV-VI, assessed approximately 6 months after completion of treatment; [ Time Frame: 5 years ]
  • Evaluate the severity, relationship, time to onset, duration, and resolution of adverse events (AEs) by Fitzpatrick skin type and gender; and [ Time Frame: 5 years ]
  • Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy. [ Time Frame: 5 years ]


Original Secondary Outcome:

  • Evaluate the incidence of hypertrophic scars or keloids in subjects by Fitzpatrick skin types IV-VI, assessed approximately 6 months after completion of treatment;
  • Evaluate the severity, relationship, time to onset, duration, and resolution of adverse events (AEs) by Fitzpatrick skin type and gender; and
  • Evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy.


Information By: Sanofi

Dates:
Date Received: August 3, 2006
Date Started: October 2005
Date Completion:
Last Updated: October 28, 2011
Last Verified: October 2011